Associate II, Chemistry, Process Development

About the role

As an Associate II, you will design and conduct research, troubleshoot, and solve problems arising during synthetic route/process development. You will also develop safe and efficient synthetic processes that can be scaled-up reliably and reproducibly while adhering to EHS and regulatory guidelines.

Responsibilities

• Operate to the highest ethical and moral standards and comply with Abzena's policies and procedures.
• Communicate effectively with clients, supervisors, colleagues, and staff.
• Participate effectively as a team player in all aspects of Abzena's business.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Lead a team in the development of new processes to manufacture Active Pharmaceutical Ingredient (API) for early development through Phase II clinical trials.
• Ensure that processes are suitable for controlling the quality of API as required by cGMP, ICH, and FDA regulations, as well as attributes conducive to successful formulation development.
• Manage the chemical process development, kilo-lab, and pilot plant scale-up of API with contributions to broader CMC and regulatory activities.
• Contribute to the planning of synthetic routes, execution, and chemical synthesis projects.
• Perform the preparation, purification, and characterization of all materials, maintaining clear and current records in a laboratory notebook.
• Conduct analytical work, attend and contribute to meetings, and write comprehensive reports.
• Purchase all necessary supplies and equipment.
• Maintain a safe, pleasant, and efficient working environment.
• Provide thorough documentation and authoring of SOPs, investigations, lab notebooks, batch records, deviations, CAPA, and other relevant technical documents.
• Follow safety procedures for organizational policies.
• Identify opportunities for improvement or optimization in current processes and implement viable solutions.
• Investigate route modifications to limit cytotoxicity until the final step to reduce the cost of goods and increase overall safety.
• Exhibit detailed record-keeping, data analysis, and chain of custody controls required for successful implementation of GMP.
• Perform other duties as assigned.

Requirements

• B.S. degree in Chemistry or Chemical Engineering and at least three years’ work experience as a process research and development chemist in an industry laboratory.
• Knowledge and experience in a GMP environment preferred.
• Knowledge and experience of analytical techniques and compound characterization.
• Strong capability in MS Office suite; experience with ERP and ELN systems is a plus.

Physical Requirements

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Frequently lift and/or move objects up to 30 pounds.
• Stand/walk during the entire length of shift.
• Use arms, hands, and fingers to handle, feel, or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.
• Ability to work with a PAPR and gown during work with high potent materials.

FLSA: Exempt